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Quality Control Analyst

Company

Enzene Biosciences Ltd

Location

pune district, pune district

Type

Full-time

We are looking for an experienced QC Analytical professional (6–12 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.


Key Responsibilities:

• Review analytical data for DS, DP, stability, method validation, and method transfer samples.

• Perform and review chromatographic and plate-based analytical techniques.

• Manage reference standards, laboratory documentation, calibration activities, and inventory.

• Handle investigations related to Deviations, OOS, OOT, CAPA, and Change Controls.

• Support equipment qualification (IQ/OQ/PQ), analyst qualification, and training activities.

• Ensure compliance with GMP, GLP, and GDP requirements.


Technical Expertise Required:

• CEX-HPLC, SE-HPLC, RP-HPLC

• ELISA, RT-PCR

• Capillary Electrophoresis (Maurice System)

• Analytical data revi...

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